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European Quality Assurance (QA) & Control Standards

White Paper Discusses the Critical Role Quality Management Plays in Complying with European Quality Assurance & Control Standards

The Western European pharmaceutical market has been growing steadily for years. This is clearly an important market, but one in which many drug manufacturers find it difficult to ensure that their quality management systems be compliant with European quality assurance standards.

Manufacturers face the burden of dealing with a separate drug agency in every country. They must contend with lingering protectionist tendencies of European governments wary of approving new drugs that compete with those produced locally. For those who want to either enter the European market or to further succeed in it or to achieve compliance with European regulatory bodies' quality control standards, a key question is: How can my pharmaceutical company obtain and maintain a marketing authorization (MA) cost-effectively and efficiently?

Sustaining Compliance to European Quality Control Standards with MasterControl

Breaking into a new market or exapanding within that market is never easy. In order to successfully break into or expand a business in Europe, US pharmaceutical companies must adhere to European quality assurance standards. This requires a high-level of compliance in regard to product design, manufacturing, labeling, etc. MasterControl’s quality assurance and control suite of applications empowers companies to control and maintain processes in accordance to the standards required by various international regulatory authorities.

Another reason to consider MasterControl's quality assurance suite of applications for help with complying with European quality control standards is the increased globalization and expanding businesses that many companies are experiencing across the globe. The possibility of miscommunication between different departments is too likely in global scenarios to risk nonconformance events and a high level of deviations. A cohesive and electronic platform is required to place different independent departments in a position in which they can communicate at any time and from virtually anywhere with each other. MasterControl's quality suite electronically streamlines communication, collaboration and provides a workspace for employees and management alike.

In order to provide better manageability to employees and to enhance the management of documentation, MasterControl Documents enables companies with a consolidated platform to store all documentation. This provides easy access to a centralized document archive and makes it easier to manage documentation procedures with exact accuracy. MasterControl Documents also helps eliminate any chance of non-conformity or deviance in business processes.

Other Features of MasterControl That Help with European QA Standards

Already adhering to ISO and FDA regulations, companies can also attain compliance with European QA standards. Another vital ingredient in bringing control in the system is to nip any issues, bugs or deviances in the bud as soon as any occurrence of these is spotted. MasterControl Customer Complaints allows users such as customers, vendors and even employees to raise an issue that is escalated for resolution without any delay.

Once an error is reported, the next step is to resolve the issues at hand on an immediate basis. MasterControl CAPA allows quick remedy for corrective action and also to prevent the error from ever being repeated again. MasterControl Deviations and MasterControl Nonconformance also play a handy role in tailoring processes to travel through the standardized route. Any divergence from the actual standard raises a deviance in the system. The respective personnel are informed of this situation against which they must take the appropriate action. In case processes still continue in the wrong direction, nonconformity is raised that clearly specifies that something has gone wrong which should have been sorted out in the first place. Therefore, MasterControl provides controls at various levels in the system so that management is facilitated to attain and sustain control as per the European quality control standards.

White Papers About European QA Standards

This white paper, titled, "The Importance of Effective Quality Management in Complying with the European QA Standards," prepared by MasterControl Inc., discusses the following:

Background about the European Medicines Agency and its role in the EU market

The significance of the European quality assurance standards as embodied in Commission Directive 2003/94/EC

Key principles of the EU GMP standards

The MasterControl Solution: How a powerful software solution can serve as a foundation for long-term compliance with European quality control standards, and therefore help ensure enduring success in the EU market.

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